Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors

Early Gastric Cancer Clinical Trial

Official title:

Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602299
• Other study ID #: gastroscopy time
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: March 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter, prospective, interventional study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in China. At the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. At the second stage, a minimal time limit will be set for each procedure based on the observational results of the first stage. The primary study outcome is focal lesion detection rate. Secondary outcomes include detection rate of early upper GI cancer, biopsy rate and adverse event rate.

Description:

China is a country with a heavy burden of gastric cancer and esophageal cancer. In 2015, the incidence/mortality of gastric cancer and esophageal cancer in China were 680000/500000 and 220000/200000, respectively. Gastroscopy is the most important means to detect early cancer of gastrointestinal tract. However, due to various factors, the miss rate of clinical significant lesions by gastroscopy is innegligible. Our previous research results showed that the detection rate of early gastric cancer and early esophageal cancer in China was only about 15%. This study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in China.

At the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. Then, researchers collect the data (including focal lesion detection rate, procedure time, detection rate of early upper GI cancer, biopsy rate and adverse event rate) and analyze the minimal procedure time. At the second stage, a minimal time limit will be set for each procedure. Every stage last two months, and potential correlations between lesion detection rate and procedure time will be investigated through subsequent statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: January 15, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)

• undergo gastroscopy with intravenous anesthesia (or conscious sedation)

Exclusion Criteria:

• Subjects with focal lesions detected by gastroscopy within 1 year

• Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endosccopists

• Emergency endoscopy and therapeutic endoscopy

• Subjects with history of esophageal or stomach surgery or endoscopic surgery

• Pregnant

• Subjects that taking antiplatelet or anticoagulant drugs which contradicts endoscopic biopsy

• Subjects with other serious complications that affect the speed of gastroscopy

• Subjects that refuse to cooperate with data collection or sign the informed consent

Related Conditions & MeSH terms

• Detection Rate
• Digestive System Neoplasms
• Early Gastric Cancer
• Gastrointestinal Neoplasms
• Gastroscopy Time

Intervention

Other:
• Set the minimum time of gastroscopy
This study contains 2 stages. At the first stage, no interventions are implemented. The researchers just observe the actual procedure time of gastroscopy. At the second stage, a minimal procedure time is set based on the observational results of the first stage.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	focal lesion detection rate	number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures	two months
Secondary	detection rate of high risk lesions	number of gastroscopy procedures that detect upper GI cancers (gastric or esophageal cancer), dysplasia and intestinal metaplasia divided by the number of all gastroscopy procedures	two months
Secondary	endoscopic biopsy rate	number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures	two months
Secondary	detection rate of neoplastic lesions	number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures	two months
Secondary	mean (median) examination time for normal EGDs without biopsy	mean (median) examination time for all normal EGDs without biopsy	two months
Secondary	rate of procedures reaching the minimal time	number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures	two months